Protocol Management for Reviewers

Release 9.5

eSirius Protocols

Protocol Management for Reviewers eProtocols Introduction This manual was revised to encompass the changes made to eSirius in Release 9.5. The new portions of the manual are indicated by ‘9.5’ in each heading and new text in red. eSiriusUsers

There are two types of eSirius users: Office and Enterprise.

Office users are IACUC staff, director, and committee members; and department veterinarians. Depending on the rights assigned to each individual, office users may access any protocol in the system.

Enterprise users are Principal Investigators and their staff. In the Expert security set-up, a group is created for each PI, and individuals are linked to those groups. Enterprise users may access only those protocols belonging to the group owner (Principal investigator) of the group to which they belong.

Access to data in the system is controlled in eSirius Expert; office users may retrieve all protocols while enterprise users may access only their own protocols.

Enterprise users may be linked to more than one group. When you login, if you have one group association eSirius will default to that group. If you have more than one, you are prompted to select the group for login. Similarly, if you have been assigned an Office & an Enterprise role you will be prompted to choose one of those roles at login.

eProtocols – Release 9.5 – July, 2006 2 Login Open your web browser and locate the URL assigned to eSirius on your institution’s website.

At the eSirius login screen type your user ID and password and click ‘Login to eSirius’. The default user ID is your first initial and last name. Your user ID and password can be changed in Expert by your eSirius Administrator.

Your homepage should appear. Veterinary reviewer and IACUC committee member reviewer home pages are similar.

The gray stripe across the top of the window displays your current location (in this example ‘Home Page’), your name (in this example, the name of the IACUC committee member is Member One), your security role, links to ‘Sign out’ and ‘Refresh’, and today’s date.

eProtocols – Release 9.5 – July, 2006 3 To the left of the page is the table of contents. Clicking on an item in the table of contents will take you to that portion of your home page. In the example above ‘Alerts’, ‘Protocol New’, ‘Protocols’ and ‘Change Password’ are the only choices. The ‘Protocol New’ section is an Alert that tells you there is an item that needs action taken. If there were more ‘Alerts’, there would be more blue stripe labeled bands - with the alerts under it.

The stripe labeled ‘Protocols’ displays the protocol access options assigned to you by the eSirius administrator.

Change Password The Password option allows you to change your password; click on password in the TOC and follow the on-page instructions.

eProtocols – Release 9.5 – July, 2006 4 Process Flow of Protocol Applications eSirius Protocol Application Process Flow

PI Revises Application for New Protocol and Resubmits to IACUC PI Submits an Coordinator Application for a New Protocol Based on time constraints and institutional procedures, IACUC Coord, may resend Ready for protocol to IACUC Coordinator NO Starts Review agenda? reviewers, or Process - Sends IACUC Coordinator committee Protocol to Returns Protocol to PI for members for Veterinarian(s) Revision comments on revision. Can also be returned YES to PI.

Veterinarian Reviews Protocol, Makes IACUC Coordinator Recommendations and Places Protocol on Returns it to IACUC Agenda Coordinator

Ready for committee review? IACUC Coordinator manages OnLine Agenda to Document Committee Decisions YES

IACUC IACUC Coordinator YES Coordinator Sends Protocol to Approved? NO documents reason Committee Members for denial and notifies PI

Committee Members YES Review Protocol and Return it to IACUC Coordinator NO IACUC Coordinator documents Needs approval and Revision? notifies PI

Note: The process flow detailed above is a suggested method for using eSirius for protocol submission and review. The most recent release of eSirius allows the IACUC coordinator to send a protocol to whomever he/she chooses – and in whatever order.

eProtocols – Release 9.5 – July, 2006 5 Using eSirius for New Protocol Submission, Review and Committee Approval

Veterinarian Reviews Protocol and Returns it to IACUC Coordinator Log in to eSirius using your UserID and Password. You are presented with your home page.

On the left of the page is a Table of Contents (TOC). Clicking on an item in the TOC will take you to that portion of your home page. Based on access granted by your e-Sirius administrator your home page may look different from the one below. In this example, the veterinarian has ‘Alert – New Protocols’. Protocols appear in this alert for the veterinarian if they have been sent to him for review by the IACUC staff. (He also has six options under the heading ‘Protocols’: Agenda Search, AAALAC compliance reports, Amendment Search, Protocol Contact Reports, Protocol Reports, and Protocol Search. For instructions on these see the heading ‘Protocol Options’ later in this manual.)

The protocols in the alert – new protocols with the workflow status of ‘Reviewer/Committee Member are those sent to you for review. In the example above, the protocol with the workflow status of ‘IACUC’ has already been reviewed by the veterinarian and returned to the IACUC office. Select the protocol to review by clicking on the hyperlink/protocol number. The protocol application is assembled into one HTML document and displayed for easy review. The table of contents may be used to go to any section, or you may scroll through the document using the scroll bar.

eProtocols – Release 9.5 – July, 2006 6 Within each section, there is a ‘Revision Notes’ field. You may read the information entered on the application, and make recommendations for change in this field. Make recommendations only on the sections that you would like to see changed – if the information presented is satisfactory do not enter any notes. Continue scrolling through the document to review each section of interest to you.

The buttons under each recommendation field are: eProtocols – Release 9.5 – July, 2006 7 a. Save Review – this will save your recommendations and take you to the submit page. Scroll through the document and make all recommendations before clicking this button. If you want to finish at a later date, make as many recommendations as you wish, click Save Review, and then from the Submit page, click home. (A future release of eSirius will have another button on the recommendation page enabling you to bookmark your place). b. Continue – Use this button when you have no recommendations but just want to go to the submit page. This button will not do the step to save. c. Return to Home Page – will take you to your home page of eSirius - it will NOT save revisions on the document.

The recommendations you make for change will be sent back to the IACUC staff, perhaps compiled with recommendations from another veterinarian – or otherwise edited, and then sent to the PI for revision.

To submit your revisions to the IACUC, click ‘Save Review’ from any point in the document. You are presented with the Submit page.

eProtocols – Release 9.5 – July, 2006 8 Note in the Protocol Information section of the submit page – the protocol number is a hyperlink which will allow you to view or print the protocol.

The Pages Under Review section lists the pages marked by you for revision.

In the section, Reviewer Submission Status’ there is a pick list to select a status for submitting to the IACUC. In the above example Electronic Signatures have not been implemented – if they were, entry of your password would be necessary to complete the page. Choose a status and click Submit to IACUC (You may also choose ‘Return to Home Page’ –allowing you to submit the revision at a later date, or ‘Clear Form” – clearing the status field only.) Once you submit your revision to the IACUC, it is no longer available for editing/revising from your homepage. The protocol will still display in the Alert - New Protocols and the work flow status will be ‘IACUC’, but if you click on the hyperlink – the assembled HTML document will display for viewing or printing only – with your recommendation(s). As other committee members make recommendations to the protocol they will be available for you to read and review. This document may be printed by selecting File/Print from the browser tool bar.

IACUC Coordinator Returns Protocol to PI for Revision After the IACUC coordinator receives the revision recommendation from the reviewers, the comments are consolidated and placed in a review recommendations section that the PI can review. The protocol is then sent back to the PI for modification.

PI Revises Application and Resubmits It to IACUC When a protocol is returned to the PI from the IACUC coordinator, it appears in ‘Alerts – New Protocols’ with the workflow status of ‘PI’. The PI clicks on the hyperlink/protocol number to access the original application – which now includes revision notes from reviewers. The PI makes the appropriate revisions and resubmits it to the IACUC coordinator.

IACUC Coordinator Sends Protocol to Committee Members Depending on responses from the investigator and standard operating procedures at your institution, the IACUC coordinator can send it back out for further committee review or send it to the next meeting agenda.

Committee Members Review Protocol and Return it to IACUC Coord.

Log in to eSirius using your UserID and Password. You are presented with your home page.

eProtocols – Release 9.5 – July, 2006 9 On the left of the page is a Table of Contents (TOC). Clicking on an item in the TOC will take you to that portion of your home page. Based on access granted by your e-Sirius administrator your home page may look different from the one below. In this example, the Committee Member has one ‘Alert’. The alert has a work flow status of ‘committee’ indicating that protocol is ready for review by this member. When this member completes his review of this protocol and sends it back to the IACUC staff, it will have a work flow status of IACUC’. (He also has three options under the heading ‘Protocols’, Agenda Search, Protocol Reports, and Protocol Search. For instructions on these see the heading ‘Protocol Options’ later in this manual.

Select the protocol to review by clicking on the hyperlink/protocol number.

eProtocols – Release 9.5 – July, 2006 10 ESirius assembles the protocol application into one HTML document. A table of contents is at the beginning of the document and you may select any section to view. In the example above, the Protocol Scientific Goals section has been marked for review by another reviewer (indicated by the dark blue arrow). You may navigate by scrolling down or selecting a section from the table of contents. In each section, there is a ‘Recommendation Notes’ field. You may read the information entered on the application, and make recommendations for change in this field. Make recommendations only on the pages that you would like to see changed – if the information presented is satisfactory do not enter any notes.

For example, to make a recommendation on the Scientific Objectives page, select that page from the table of contents or by scrolling down to it, and enter your revision notes in the ‘Recommendation Notes’ field. eProtocols – Release 9.5 – July, 2006 11 The buttons under the recommendations field are: a. Save Review – this will save your recommendation and take you to the Submit Page. If you want to enter recommendations on several pages, don’t save the review until you have completed all of them. b. Continue – use this button to return to the submit page when you have no recommendations for revision on the protocol. It does not execute the save process, so use it only when you have no recommendations. c. Return to Home Page – this will take you back to your home page. It will NOT save any recommendation notes you have entered.

The recommendations you make for change will be sent back to the IACUC staff, perhaps compiled with recommendations from another reviewer – or otherwise edited. The protocol may have been sent to the PI for revision before it was sent to the reviewers.

By clicking Save Review from any point in the application, you will be taken to the Submit Page.

eProtocols – Release 9.5 – July, 2006 12 Note in the Protocol Information section of the submit page – the protocol number is a hyperlink which will allow you to view or print the protocol.

In the pages under review section, you can see that there was a prior revision to this protocol application. The Scientific Goals page was marked by a reviewer, and the protocol was sent back to the PI for revision. Your recommendation to revise the objectives page is Revision #2.

There is a pick list to select a status for submitting to the IACUC. In the above example the Electronic Signatures option has not been implemented; if it had, entry of your password would be necessary to complete the page. Choose a status and click Submit to IACUC (You may also choose ‘Return to Home Page’ –allowing you to submit the revision at a later date, or clear form – clearing the status field only.) Once you submit your revision to the IACUC, it is no longer

eProtocols – Release 9.5 – July, 2006 13 available for editing/revising from your homepage. The protocol will still display in the Alert - New Protocols and the work flow status will be ‘IACUC’, but if you click on the hyperlink – the assembled HTML document will display for viewing or printing only – with your recommendation(s). As other committee members make recommendations to the protocol they will be available for you to read and review. This document may be printed by selecting File/Print from the browser tool bar.

Second reviewer

A second reviewer selects the protocol to review. If any other reviewers have made comments, he will be able to see them. Select the hyperlink protocol number to review a protocol.

eProtocols – Release 9.5 – July, 2006 14 When the protocol opens and the TOC displays, the second reviewer can see that two sections have been marked for revision, Goals and Objectives. When he clicks on the Goals section he sees the following:

The PI’s revised goals are displayed at the top. His original text is in black, the additions are in blue, and any deletions would be displayed in red with a strikethrough. The reviewer notes are in the red boxes in the middle. This reviewer could make more comments if he felt the response was not satisfactory.

He can also look at the objectives section (which is the current revision and has not yet been sent to the PI for change). In the objectives section (below) this reviewer can recommendation notes entered by the first reviewer ‘the objectives are weak’ and can see the original text from the PI ‘objectives’. If he wants he may enter additional recommendation notes, or just proceed to reviewing the other sections of the protocol.

eProtocols – Release 9.5 – July, 2006 15 When the reviewer has completed his review of the protocol, he clicks on ‘Save Review’ and then, from the submit page, ‘Submit to IACUC’.

IACUC Coordinator Places Protocol on Agenda

When all reviewers have returned comments the protocol is placed on the meeting agenda by selecting the protocol from the Alert. When the protocol is placed on the agenda, it is no longer available for editing from your alerts section.

Other Protocol Options for Veterinarians and Reviewers

The eSirius administrator assigns user access to Options. Some or all of the following may be available on a user’s home page – depending on assignments made in Expert to the user.

Protocol Search (9.5 change) This feature contains multiple filters by which you can select protocols from the database for viewing or printing. Investigators select from only their own protocols, and office users may view print any protocol. In addition, the IACUC staff can edit a protocol and can send emails to investigators of selected protocols. Release 9.5 includes the ability to sort the protocols returned from a search.

eProtocols – Release 9.5 – July, 2006 16 Protocol Reports Multiple filters can be combined with an ‘and/or’ option to generate various ‘count of protocols’ and ‘list of protocols’ reports.

Protocol Contact Reports Multiple filter options allow the user to customize two reports a. a list of all protocol contacts b. a list of protocol contacts by protocol.

AAALAC Compliance Reports Reports can be generated to meet compliance guidelines. Multiple filters can be combined with an ‘and/or’ option to produce reports detailing:  Analgesic/Anesthetic Agents  Animal Usage by Non-Surgical Procedure (detailed and summary)  Animal Usage by Surgical Procedure  Euthanasia Methods by Species  Hazardous Agents by Species  Location and Types of Rodent Surgery  Multiple Major Recovery Surgical Procedures  Restraint by Species  Use Locations by Species

Agenda Search This option may be assigned to office users including IACUC staff, committee members, and veterinarians. It allows the user to access any meeting agenda for review. Choose agenda search from your home page, select a meeting date from the pick list and click search.

In this example, an IACUC member is searching for the upcoming meeting date to view protocols already sent to the agenda.

eProtocols – Release 9.5 – July, 2006 17 The agenda search option allows office users to view an agenda and view each protocol if desired. To view a protocol, click on the protocol number/hyperlink. The agenda search option allows IACUC staff the additional option of adding to the minutes of past meetings. Changes to status may not be made through the agenda search.

eProtocols – Release 9.5 – July, 2006 18 Annual Reviews

IACUC Processes Annual Review Form w/o Modifications from PI When the PI has completed the annual review form and submitted it to the IACUC, it remains in the Alert—Annual Review, but the workflow status changes to IACUC. This is the signal to the IACUC staff to open and process the renewal.

The IACUC has many options at this point in the review process. After reading the progress report, you may send the protocol back to the PI with recommendation notes, to any of the reviewers, to the agenda, or you may approve or expire it. In this example, the IACUC staff will approve it. In the following section, a protocol is submitted with amendments and the IACUC sends it to a reviewer.

Annual Review With Modifications

IACUC Opens Annual Renewal with Modification Submitted by PI Protocol 2006-0051 in the alert – annual review is ready for processing by the IACUC staff. Click on the hyperlink/protocol number to open it.

At this point the review process is much the same as for new protocol reviews. The IACUC staff has several options:  IACUC Amendment Review – the review document is opened (the same way it is opened for a new protocol review) with recommendation boxes on only the section chosen by the PI for amendment.  Select New Pages for Review – opens the Choose Amendment Sections page to allow the IACUC staff to select additional pages to be amended.  Submit to Reviewer or Committee Members - the reviewer also sees the review document with recommendation boxes on only the section(s) chosen by the PI for amendment.  Submit to PI – allows the PI to respond to recommendations about any previously selected sections.  Approve or Expire now – IACUC may approve or expire the protocol by selecting an effective date, typing YES, and clicking either the approve or expire button

eProtocols – Release 9.5 – July, 2006 19 Reviewer Opens Protocol Annual Renewal with Modifications

Reviewer sees a protocol in Alert-Annual Review, with a workflow status of ‘reviewer’. When he opens it he sees the entire protocol with recommendation boxes on only the sections marked for modifications. He may:  Enter a recommendation on the section marked for modifications, if necessary  Return to the submit page by either saving his recommendation or clicking continue  Enter a reviewer status for submitting to IACUC staff and  Submit his review to the IACUC staff

eProtocols – Release 9.5 – July, 2006 20 In this example, the reviewer wants a justification for additional animals. After entering his recommendation, above, he clicks save amendment review and is taken to the annual review/submit page.

eProtocols – Release 9.5 – July, 2006 21 When reviewer sends protocol back to IACUC (Submit to IACUC button) the workflow status of the protocol will change to IACUC.

IACUC Returns Annual Review with Modifications to PI for Revision Protocol 2006-0051 was sent to a reviewer, the reviewer made a recommendation and now the IACUC staff will send the protocol back to the PI for revision. Note the alert above indicates the workflow status = IACUC. When the IACUC staff opens the protocol, the next step is the same as for new protocols – IACUC staff copies reviewers’ recommendations into the IACUC recommendation and is then able to send the protocol to the PI.

PI Revises Original Annual Renewal with Modification Form and Resubmits to IACUC Staff PI opens returned protocol from the Alert – Annual Reviews when the workflow status = PI

eProtocols – Release 9.5 – July, 2006 22 PI may edit the progress report, reason for amendment and the page he originally selected to amend. In the above example, he should edit the reason eProtocols – Release 9.5 – July, 2006 23 for amendment and change the number of additional animals requested. Because the page ‘Mouse—Humane Use Animal Categories’ is marked with a recommendation, the PI must make a change to that page.

After editing his page under amendment, clicking continue will allow the PI to add another page for amendment, if necessary. He then may resubmit the protocol to the IACUC.

IACUC Completes Annual Review of a Protocol with Modifications After opening the protocol from the Alert – Annual Review, the IACUC staff again has several options:  Review the revision from the PI – IACUC Review  Send it to a reviewer – Submit to reviewer  Send it to all committee members – Submit to committee members  Send it directly to the agenda for the next meeting – Submit for full committee review  Approve it prior to the meeting – Approve Now

Annual Review – Withdrawal If an investigator wishes to withdraw the protocol from annual review, he opens the annual renewal notice from the Alert – Annual Reviews on his home page, indicates he is withdrawing the protocol and submits it to the IACUC. The IACUC staff then opens the protocol from the Alert – Annual Reviews and takes appropriate action, ie. changes the protocol status.

Continuation/Three Year Reviews An alert goes to both the PI and the IACUC staff a set number of days prior to the expiration date. (Number of days determined in IACUC setup/Preferences).

Note: the protocol year in the above figure should read ‘3’. This protocol was forced into three year renewal for demonstration purposes.

PI submits 3rd Year Renewal

The 3rd year renewal applications appear in the Alert-New Protocols after the PI completes the form and submits it. At this point they are treated exactly as new protocol applications, differentiated by the document type ‘full review’.

eProtocols – Release 9.5 – July, 2006 24 IACUC Staff Processes 3rd Year Renewal

The 3rd year renewal applications appear in the Alert-New Protocols after the PI completes the form and submits it. At this point they are treated exactly as new protocol applications, differentiated by the document type ‘full review’. IACUC staff may edit, review, send to reviewers, send to agenda or approve now. If sent to the agenda, protocols will be listed in the separate, 3rd year renewal section.

Amendments to Protocols

PI Submits an Amendment for an Existing Protocol This option is used when the investigator makes a change to a protocol at a time other than the annual renewal. The existing protocol must be approved.

IACUC Processes New Amendment Application IACUC staff selects amendment application from Alerts and from this point forward it is subject to the same review process as new and continuation applications.

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